Complementary technologies accelerate and help assure success in the drug development process Princeton, N.J., October 4, 2021 – Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced the completion of the previously announced transaction to acquire Pinnacle 21, a leading provider of SaaS solutions for clinical data fitness, regulatory compliance and submission readiness. … Continued
Raises full year 2021 guidance and announces deal to acquire Pinnacle 21 PRINCETON, N.J.—August 5, 2021– Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today reported its financial results for the second quarter of fiscal year 2021. Highlights: Revenue was $70.1 million, representing growth of 15% over the second quarter of 2020 Net loss … Continued
Transaction expected to be accretive to Certara’s revenue, revenue growth and adjusted EBITDA margin Princeton, N.J., August 5, 2021 – Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced it has signed a definitive agreement to acquire Pinnacle 21 for $310 million in cash and stock. Pinnacle 21’s software tools are used to … Continued
This blog discusses the development of pharmacokinetic CDISC data standards and the impact of building them for electronic regulatory submissions.
Data heterogeneity is a regulatory reviewer’s nightmare. Some sponsors talk about patient “gender” whereas others list the patient’s “sex.” What about date formats? Do you use the American-style month-day-year format or the European-style day-month-year? Inconsistent data presentation makes both collaborating on drug development projects and reviewing regulatory submissions more difficult. To address this challenge, the … Continued
In December 2014, the US FDA published a binding guidance document, Guidance for Industry – Providing Regulatory Submissions in Electronic Format – Standardized Study Data, that establishes a requirement for submitting study data (clinical and non-clinical) in electronic format conforming to CDISC standards. The study data requirement is not retroactive and will only apply to … Continued
A recent report by Deloitte identified the #1 trend in the life sciences market as an increased focus on patient safety and enforcement. While it seems obvious to consider safety issues in approved drugs, regulatory agencies such as the FDA and EMA (European Medicines Agency) are extending their scrutiny to the entire drug development process, … Continued